Takeda's Dengue Vaccine Candidate Under FDA Priority Review

The FDA has accepted and granted priority review to Takeda Pharmaceutical Co Ltd's TAK Biologics License Application (BLA) for TAK-003, the company's investigational dengue vaccine candidate.
In the U.S., TAK-003 is being evaluated for the prevention of dengue disease caused by any dengue virus serotype in individuals four years through 60 years of age.
Dengue is a mosquito-borne virus endemic in more than 125 countries.
The TAK-003 application is supported by safety and efficacy data from the pivotal Phase 3 trial. The dengue vaccine candidate met its primary endpoint by preventing 80.2% of symptomatic dengue cases at 12 months.
In addition, TAK-003 prevented 90.4% of hospitalizations at 18 months and, in an exploratory analysis, demonstrated protection against dengue fever through 4.5 years (54 months) after vaccination.
Exploratory analyses showed that throughout the 4.5-year study follow-up, TAK-003 prevented 84% of hospitalized dengue cases and 61% of symptomatic dengue cases in the overall population, including both seropositive and seronegative individuals.
TAK-003 has not been approved by the FDA or any other health authority outside of Indonesia.
In October 2022, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the approval of TAK-003.
Price Action: TAK shares closed at $14.23 on Tuesday.